Zimmer Affixus Antegrade Femoral Nailing System recalled for fracture risk
Contact your surgeon about Zimmer Affixus nail
Zimmer, Inc. is recalling certain Affixus 9 mm, 300 mm Left Trochanteric Femoral Nails (Model 815609300, Lot 66717600) because the implant shaft may be undersized, which could cause it to crack or break inside the body. If the nail fractures, patients may experience pain, improper bone healing, tissue damage, or need another surgery.
- If you received this implant, contact your surgeon immediately to discuss whether you are affected
- Do not stop treatment or remove the implant without medical guidance
- Ask your surgeon about monitoring or follow-up imaging
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0974-2026More Zimmer Biomet recalls
- FDA-Device2026-07-01Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide recalled for plastic breakage during surgery
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- FDA-Device2026-07-01Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage during surgery
- FDA-Device2026-07-01Zimmer Persona Revision Femoral Distal Augment recalled for wrong component in package
- FDA-Device2026-07-01Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for plastic breakage risk during surgery
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